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Product NDC Code | 43479-111 | ||||
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Drug Name | Eradikate salicylic acid acne treatment |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 103568 | ||||
Application Number | M006 | ||||
Labeler Name | KATE SOMERVILLE SKINCARE, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS SALICYLIC ACID- 2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.USE 1 TO 2 TIMES WEEKLY GENTLY APPLY AN EVEN LAYER TO CLEAN, WET SKIN USING CIRCULAR MOTIONS LEAVE ON FOR 1 MINUTE GENTLY WASH OFF AND PAT DRY.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Glycereth-7 Trimethyl Ether, Cetyl Alcohol, Caprylic/Capric Triglyceride, Isopropyl Isostearate,Trimethylolpropane Tricaprylate/Tricaprate, Steareth-21, Dimethicone, Glycereth-18 Ethylhexanoate, Propanediol, Steareth-2, Retinyl Propionate, Hexylresorcinol, Oligopeptide-10, Proline, Hydroxyproline, Ethyl Linoleate, Sodium Hyaluronate, Saccharide Isomerate, Sodium PCA, Panthenol, Melaleuca Alternifolia Leaf Oil, Laminaria Digitata Extract, Boswellia Serrata Extract, Honey Extract, Oryza Sativa (Rice) Bran Extract, Chlorella Vulgaris Extract, Sea Water, Glycerin, Butylene Glycol, Glycereth-18, Trimethylpentanediol/Adipic Acid Copolymer, 1,2-Hexanediol, Polyacrylate Crosspolymer-6, Polymethylsilsesquioxane/Silica Crosspolymer, Aminomethyl Propanol, Caprylhydroxamic Acid, Disodium EDTA, Phenoxyethanol, Sodium Benzoate, Ethylhexylglycerin, Lavandula Angustifolia (Lavender) Oil, Disodium Carboxyethyl Siliconate, T-Butyl Alcohol, Linalool, Limonene, Iron Oxides (Ci 77491).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES FOR THE TREATMENT OF ACNE HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES
Purpose
Information about the drug product’s indications for use.PURPOSE ACNE MEDICATION
Spl product data elements
Usually a list of ingredients in a drug product.ERADIKATE SALICYLIC ACID ACNE TREATMENT SALICYLIC ACID WATER GLYCERETH-7 TRIMETHYL ETHER CETYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES ISOPROPYL ISOSTEARATE TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE STEARETH-21 DIMETHICONE GLYCERETH-18 ETHYLHEXANOATE PROPANEDIOL STEARETH-2 RETINYL PROPIONATE HEXYLRESORCINOL OLIGOPEPTIDE-10 PROLINE HYDROXYPROLINE ETHYL LINOLEATE HYALURONATE SODIUM SACCHARIDE ISOMERATE SODIUM PYRROLIDONE CARBOXYLATE PANTHENOL MELALEUCA ALTERNIFOLIA LEAF LAMINARIA DIGITATA BOSWELLIA SERRATA WHOLE HONEY RICE BRAN CHLORELLA VULGARIS GLYCERIN BUTYLENE GLYCOL GLYCERETH-18 TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) 1,2-HEXANEDIOL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) AMINOMETHYLPROPANOL CAPRYLHYDROXAMIC ACID EDETATE DISODIUM PHENOXYETHANOL SODIUM BENZOATE ETHYLHEXYLGLYCERIN LAVENDER OIL DISODIUM CARBOXYETHYL SILICONATE TERT-BUTYL ALCOHOL LINALOOL, (+)- LIMONENE, (+)- FERRIC OXIDE RED SALICYLIC ACID SALICYLIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.0-Image_EradiKate Salicylic Acid Treatment_1oz
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR. AVOID CONTACT WITH EYES. IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS FOR EXTERNAL USE ONLY
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API